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Yakov Gologorsky, John J. Knightly, John H. Chi and Michael W. Groff

Object

The rates of lumbar spinal fusion operations have increased dramatically over the past 2 decades, and several studies based on administrative databases such as the Nationwide Inpatient Sample (NIS) have suggested that the greatest rise is in the general categories of degenerative disc disease and disc herniation, neither of which is a well-accepted indication for lumbar fusion. The administrative databases classify cases with the International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM). The ICD-9-CM discharge codes are not generated by surgeons but rather are assigned by trained hospital medical coders. It is unclear how accurately they capture the surgeon's indication for fusion. The authors sought to compare the ICD-9-CM code(s) assigned by the medical coder to the surgeon's indication based on a review of the medical chart.

Methods

A retrospective review was undertaken of all lumbar fusions performed at our institution by the department of neurosurgery between 8/1/2011 and 8/31/2013. Based on the authors' review, the indication for fusion for each case was categorized as spondylolisthesis, deformity, tumor, infection, nonpathological fracture, pseudarthrosis, adjacent-level degeneration, stenosis, degenerative disc pathology, or disc herniation. These surgeon diagnoses were compared with the primary ICD-9-CM codes that were submitted to administrative databases.

Results

There were 178 lumbar fusion operations performed for 170 hospital admissions. There were 44 hospitalizations in which fusion was performed for tumor, infection, or nonpathological fracture; the remaining 126 were for degenerative diagnoses. For these degenerative cases, the primary ICD-9-CM diagnosis matched the surgeon's diagnosis in only 61 of 126 degenerative cases (48.4%). When both the primary and all secondary ICD-9-CM diagnoses were considered, the indication for fusion was identified in 100 of 126 cases (79.4%).

Conclusions

Characterizing indications for fusion based solely on primary ICD-9-CM codes extracted from large administrative databases does not accurately reflect the surgeon's indication. While these databases may accurately describe national rates of lumbar fusion surgery, the lack of fidelity in the source codes limits their role in accurately identifying indications for surgery. Studying relationships among indications, complications, and outcomes stratified solely by ICD-9-CM codes is not well founded.

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Yakov Gologorsky, John J. Knightly, Yi Lu, John H. Chi and Michael W. Groff

Object

Large administrative databases have assumed a major role in population-based studies examining health care delivery. Lumbar fusion surgeries specifically have been scrutinized for rising rates coupled with ill-defined indications for fusion such as stenosis and spondylosis. Administrative databases classify cases with the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). The ICD-9-CM discharge codes are not designated by surgeons, but rather are assigned by trained hospital medical coders. It is unclear how accurately they capture the surgeon's indication for fusion. The authors first sought to compare the ICD-9-CM code(s) assigned by the medical coder according to the surgeon's indication based on a review of the medical chart, and then to elucidate barriers to data fidelity.

Methods

A retrospective review was undertaken of all lumbar fusions performed in the Department of Neurosurgery at the authors' institution between August 1, 2011, and August 31, 2013. Based on this review, the indication for fusion in each case was categorized as follows: spondylolisthesis, deformity, tumor, infection, nonpathological fracture, pseudarthrosis, adjacent-level degeneration, stenosis, degenerative disc disease, or disc herniation. These surgeon diagnoses were compared with the primary ICD-9-CM codes that were generated by the medical coders and submitted to administrative databases. A follow-up interview with the hospital's coders and coding manager was undertaken to review causes of error and suggestions for future improvement in data fidelity.

Results

There were 178 lumbar fusion operations performed in the course of 170 hospital admissions. There were 44 hospitalizations in which fusion was performed for tumor, infection, or nonpathological fracture. Of these, the primary diagnosis matched the surgical indication for fusion in 98% of cases. The remaining 126 hospitalizations were for degenerative diseases, and of these, the primary ICD-9-CM diagnosis matched the surgeon's diagnosis in only 61 (48%) of 126 cases of degenerative disease. When both the primary and all secondary ICD-9-CM diagnoses were considered, the indication for fusion was identified in 100 (79%) of 126 cases. Still, in 21% of hospitalizations, the coder did not identify the surgical diagnosis, which was in fact present in the chart. There are many different causes of coding inaccuracy and data corruption. They include factors related to the quality of documentation by the physicians, coder training and experience, and ICD code ambiguity.

Conclusions

Researchers, policymakers, payers, and physicians should note these limitations when reviewing studies in which hospital claims data are used. Advanced domain-specific coder training, increased attention to detail and utilization of ICD-9-CM diagnoses by the surgeon, and improved direction from the surgeon to the coder may augment data fidelity and minimize coding errors. By understanding sources of error, users of these large databases can evaluate their limitations and make more useful decisions based on them.

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Charles H. Crawford III, Steven D. Glassman, Praveen V. Mummaneni, John J. Knightly and Anthony L. Asher

OBJECTIVE

The relief of leg symptoms by surgical decompression for lumbar stenosis is well supported by the literature. Less is known about the effect on back pain. Some surgeons believe that the relief of back pain should not be an expected outcome of decompression and that substantial back pain may be a contraindication to decompression only; therefore, stabilization may be recommended for patients with substantial preoperative back pain even in the absence of well-accepted indications for stabilization such as spondylolisthesis, scoliosis, or sagittal malalignment. The purpose of this study is to determine if patients with lumbar stenosis and substantial back pain—in the absence of spondylolisthesis, scoliosis, or sagittal malalignment—can obtain significant improvement after decompression without fusion or stabilization.

METHODS

Analysis of the National Neurosurgery Quality and Outcomes Database (N2QOD) identified 726 patients with lumbar stenosis (without spondylolisthesis or scoliosis) and a baseline back pain score ≥ 5 of 10 who underwent surgical decompression only. No patient was reported to have significant spondylolisthesis, scoliosis, or sagittal malalignment. Standard demographic and surgical variables were collected, as well as patient outcomes including back and leg pain scores, Oswestry Disability Index (ODI), and EuroQoL 5D (EQ-5D) at baseline and 3 and 12 months postoperatively.

RESULTS

The mean age of the cohort was 65.6 years, and 407 (56%) patients were male. The mean body mass index was 30.2 kg/m2, and 40% of patients had 2-level decompression, 29% had 3-level decompression, 24% had 1-level decompression, and 6% had 4-level decompression. The mean estimated blood loss was 130 ml. The mean operative time was 100.85 minutes. The vast majority of discharges (88%) were routine home discharges. At 3 and 12 months postoperatively, there were significant improvements from baseline for back pain (7.62 to 3.19 to 3.66), leg pain (7.23 to 2.85 to 3.07), EQ-5D (0.55 to 0.76 to 0.75), and ODI (49.11 to 27.20 to 26.38).

CONCLUSIONS

Through the 1st postoperative year, patients with lumbar stenosis—without spondylolisthesis, scoliosis, or sagittal malalignment—and clinically significant back pain improved after decompression-only surgery.

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Rishi K. Wadhwa, Junichi Ohya, Todd D. Vogel, Leah Y. Carreon, Anthony L. Asher, John J. Knightly, Christopher I. Shaffrey, Steven D. Glassman and Praveen V. Mummaneni

OBJECTIVE

The aim of this paper was to use a prospective, longitudinal, multicenter outcome registry of patients undergoing surgery for lumbar degenerative disease in order to assess the incidence and factors associated with 30-day reoperation and 90-day readmission.

METHODS

Prospectively collected data from 9853 patients from the Quality and Outcomes Database (QOD; formerly known as the N2QOD [National Neurosurgery Quality and Outcomes Database]) lumbar spine registry were retrospectively analyzed. Multivariate binomial regression analysis was performed to identify factors associated with 30-day reoperation and 90-day readmission after surgery for lumbar degenerative disease. A subgroup analysis of Medicare patients stratified by age (< 65 and ≥ 65 years old) was also performed. Continuous variables were compared using unpaired t-tests, and proportions were compared using Fisher’s exact test.

RESULTS

There was a 2% reoperation rate within 30 days. Multivariate analysis revealed prolonged operative time during the index case as the only independent factor associated with 30-day reoperation. Other factors such as preoperative diagnosis, body mass index (BMI), American Society of Anesthesiologists (ASA) class, diabetes, and use of spinal implants were not associated with reoperations within 30 days. Medicare patients < 65 years had a 30-day reoperation rate of 3.7%, whereas those ≥ 65 years had a 30-day reoperation rate of 2.2% (p = 0.026). Medicare beneficiaries younger than 65 years undergoing reoperation within 30 days were more likely to be women (p = 0.009), have a higher BMI (p = 0.008), and have higher rates of depression (p < 0.0001). The 90-day readmission rate was 6.3%. Multivariate analysis demonstrated that higher ASA class (OR 1.46 per class, 95% CI 1.25–1.70) and history of depression (OR 1.27, 95% CI 1.04–1.54) were factors associated with 90-day readmission. Medicare beneficiaries had a higher rate of 90-day readmissions compared with those who had private insurance (OR 1.43, 95% CI 1.17–1.76). Medicare patients < 65 years of age were more likely to be readmitted within 90 days after their index surgery compared with those ≥ 65 years (10.8% vs 7.7%, p = 0.017). Medicare patients < 65 years of age had a significantly higher BMI (p = 0.001) and higher rates of depression (p < 0.0001).

CONCLUSIONS

In this analysis of a large prospective, multicenter registry of patients undergoing lumbar degenerative surgery, multivariate analysis revealed that prolonged operative time was associated with 30-day reoperation. The authors found that factors associated with 90-day readmission included higher ASA class and a history of depression. The 90-day readmission rates were higher for Medicare beneficiaries than for those who had private insurance. Medicare patients < 65 years of age were more likely to undergo reoperation within 30 days and to be readmitted within 90 days after their index surgery.

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Anthony L. Asher, Silky Chotai, Clinton J. Devin, Theodore Speroff, Frank E. Harrell Jr., Hui Nian, Robert S. Dittus, Praveen V. Mummaneni, John J. Knightly, Steven D. Glassman, Mohamad Bydon, Kristin R. Archer, Kevin T. Foley and Matthew J. McGirt

OBJECTIVE

Prospective longitudinal outcomes registries are at the center of evidence-driven health care reform. Obtaining real-world outcomes data at 12 months can be costly and challenging. In the present study, the authors analyzed whether 3-month outcome measurements sufficiently represent 12-month outcomes for patients with degenerative lumbar disease undergoing surgery.

METHODS

Data from 3073 patients undergoing elective spine surgery for degenerative lumbar disease were entered into a prospective multicenter registry (N2QOD). Baseline, 3-month, and 12-month follow-up Oswestry Disability Index (ODI) scores were recorded. The absolute differences between actual 12- and 3-month ODI scores was evaluated. Additionally, the authors analyzed the absolute difference between actual 12-month ODI scores and a model-predicted 12-month ODI score (the model used patients' baseline characteristics and actual 3-month scores). The minimal clinically important difference (MCID) for ODI of 12.8 points and the substantial clinical benefit (SCB) for ODI of 18.8 points were used based on the previously published values. The concordance rate of achieving MCID and SCB for ODI at 3-and 12-months was computed.

RESULTS

The 3-month ODI scores differed from 12-month scores by an absolute difference of 11.9 ± 10.8, and predictive modeling estimations of 12-month ODI scores differed from actual 12-month scores by a mean (± SD) of 10.7 ± 9.0 points (p = 0.001). Sixty-four percent of patients (n = 1982) achieved an MCID for ODI at 3 months in comparison with 67% of patients (n = 2088) by 12 months; 51% (n = 1731) and 61% (n = 1860) of patients achieved SCB for ODI at 3 months and 12 months, respectively. Almost 20% of patients had ODI scores that varied at least 20 points (the point span of an ODI functional category) between actual 3- and 12-month values. In the aggregate analysis of achieving MCID, 77% of patients were concordant and 23% were discordant in achieving or not achieving MCID at 3 and 12 months. The discordance rates of achieving or not achieving MCID for ODI were in the range of 19% to 27% for all diagnoses and treatments (decompression with and without fusion). The positive and negative predictive value of 3-months ODI to predict 12-month ODI was 86% and 60% for MCID and 82% and 67% for SCB.

CONCLUSIONS

Based on their findings, the authors conclude the following: 1) Predictive methods for functional outcome based on early patient experience (i.e., baseline and/or 3-month data) should be used to help evaluate the effectiveness of procedures in patient populations, rather than serving as a proxy for long-term individual patient experience. 2) Prospective longitudinal registries need to span at least 12 months to determine the effectiveness of spine care at the individual patient and practitioner level.

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Clinton J. Devin, Mohamad Bydon, Mohammed Ali Alvi, Panagiotis Kerezoudis, Inamullah Khan, Ahilan Sivaganesan, Matthew J. McGirt, Kristin R. Archer, Kevin T. Foley, Praveen V. Mummaneni, Erica F. Bisson, John J. Knightly, Christopher I. Shaffrey and Anthony L. Asher

OBJECTIVE

Back pain and neck pain are two of the most common causes of work loss due to disability, which poses an economic burden on society. Due to recent changes in healthcare policies, patient-centered outcomes including return to work have been increasingly prioritized by physicians and hospitals to optimize healthcare delivery. In this study, the authors used a national spine registry to identify clinical factors associated with return to work at 3 months among patients undergoing a cervical spine surgery.

METHODS

The authors queried the Quality Outcomes Database registry for information collected from April 2013 through March 2017 for preoperatively employed patients undergoing cervical spine surgery for degenerative spine disease. Covariates included demographic, clinical, and operative variables, and baseline patient-reported outcomes. Multiple imputations were used for missing values and multivariable logistic regression analysis was used to identify factors associated with higher odds of returning to work. Bootstrap resampling (200 iterations) was used to assess the validity of the model. A nomogram was constructed using the results of the multivariable model.

RESULTS

A total of 4689 patients were analyzed, of whom 82.2% (n = 3854) returned to work at 3 months postoperatively. Among previously employed and working patients, 89.3% (n = 3443) returned to work compared to 52.3% (n = 411) among those who were employed but not working (e.g., were on a leave) at the time of surgery (p < 0.001). On multivariable logistic regression the authors found that patients who were less likely to return to work were older (age > 56–65 years: OR 0.69, 95% CI 0.57–0.85, p < 0.001; age > 65 years: OR 0.65, 95% CI 0.43–0.97, p = 0.02); were employed but not working (OR 0.24, 95% CI 0.20–0.29, p < 0.001); were employed part time (OR 0.56, 95% CI 0.42–0.76, p < 0.001); had a heavy-intensity (OR 0.42, 95% CI 0.32–0.54, p < 0.001) or medium-intensity (OR 0.59, 95% CI 0.46–0.76, p < 0.001) occupation compared to a sedentary occupation type; had workers’ compensation (OR 0.38, 95% CI 0.28–0.53, p < 0.001); had a higher Neck Disability Index score at baseline (OR 0.60, 95% CI 0.51–0.70, p = 0.017); were more likely to present with myelopathy (OR 0.52, 95% CI 0.42–0.63, p < 0.001); and had more levels fused (3–5 levels: OR 0.46, 95% CI 0.35–0.61, p < 0.001). Using the multivariable analysis, the authors then constructed a nomogram to predict return to work, which was found to have an area under the curve of 0.812 and good validity.

CONCLUSIONS

Return to work is a crucial outcome that is being increasingly prioritized for employed patients undergoing spine surgery. The results from this study could help surgeons identify at-risk patients so that preoperative expectations could be discussed more comprehensively.

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Anthony L. Asher, Panagiotis Kerezoudis, Praveen V. Mummaneni, Erica F. Bisson, Steven D. Glassman, Kevin T. Foley, Jonathan R. Slotkin, Eric A. Potts, Mark E. Shaffrey, Christopher I. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Kai-Ming Fu, Clinton J. Devin, Kristin R. Archer, Silky Chotai, Andrew K. Chan, Michael S. Virk and Mohamad Bydon

OBJECTIVE

Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis.

METHODS

The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen’s effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO.

RESULTS

A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3–26.5 points for ODI, 0.04–0.3 points for EQ-5D, 0.6–4.5 points for NRS-LP, and 0.5–4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort.

CONCLUSIONS

The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.

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Andrew K. Chan, Erica F. Bisson, Mohamad Bydon, Steven D. Glassman, Kevin T. Foley, Eric A. Potts, Christopher I. Shaffrey, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Kai-Ming Fu, Jonathan R. Slotkin, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Silky Chotai, Anthony M. DiGiorgio, Alvin Y. Chan, Regis W. Haid and Praveen V. Mummaneni

OBJECTIVE

The American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data, to measure the safety and quality of neurosurgical procedures, including spinal surgery. Differing results from recent randomized controlled trials have established a need to clarify the groups that would most benefit from surgery for degenerative lumbar spondylolisthesis. In the present study, the authors compared patients who were the most and the least satisfied following surgery for degenerative lumbar spondylolisthesis.

METHODS

This was a retrospective analysis of a prospective, national longitudinal registry including patients who had undergone surgery for grade 1 degenerative lumbar spondylolisthesis. The most and least satisfied patients were identified based on an answer of “1” and “4,” respectively, on the North American Spine Society (NASS) Satisfaction Questionnaire 12 months postoperatively. Baseline demographics, clinical variables, surgical parameters, and outcomes were collected. Patient-reported outcome measures, including the Numeric Rating Scale (NRS) for back pain, NRS for leg pain, Oswestry Disability Index (ODI), and EQ-5D (the EuroQol health survey), were administered at baseline and 3 and 12 months after treatment.

RESULTS

Four hundred seventy-seven patients underwent surgery for grade 1 degenerative lumbar spondylolisthesis in the period from July 2014 through December 2015. Two hundred fifty-five patients (53.5%) were the most satisfied and 26 (5.5%) were the least satisfied. Compared with the most satisfied patients, the least satisfied ones more often had coronary artery disease (CAD; 26.9% vs 12.2%, p = 0.04) and had higher body mass indices (32.9 ± 6.5 vs 30.0 ± 6.0 kg/m2, p = 0.02). In the multivariate analysis, female sex (OR 2.9, p = 0.02) was associated with the most satisfaction. Notably, the American Society of Anesthesiologists (ASA) class, smoking, psychiatric comorbidity, and employment status were not significantly associated with satisfaction. Although there were no significant differences at baseline, the most satisfied patients had significantly lower NRS back and leg pain and ODI scores and a greater EQ-5D score at 3 and 12 months postoperatively (p < 0.001 for all).

CONCLUSIONS

This study revealed that some patient factors differ between those who report the most and those who report the least satisfaction after surgery for degenerative lumbar spondylolisthesis. Patients reporting the least satisfaction tended to have CAD or were obese. Female sex was associated with the most satisfaction when adjusting for potential covariates. These findings highlight several key factors that could aid in setting expectations for outcomes following surgery for degenerative lumbar spondylolisthesis.

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Praveen V. Mummaneni, Erica F. Bisson, Panagiotis Kerezoudis, Steven Glassman, Kevin Foley, Jonathan R. Slotkin, Eric Potts, Mark Shaffrey, Christopher I. Shaffrey, Domagoj Coric, John Knightly, Paul Park, Kai-Ming Fu, Clinton J. Devin, Silky Chotai, Andrew K. Chan, Michael Virk, Anthony L. Asher and Mohamad Bydon

OBJECTIVE

Lumbar spondylolisthesis is a degenerative condition that can be surgically treated with either open or minimally invasive decompression and instrumented fusion. Minimally invasive surgery (MIS) approaches may shorten recovery, reduce blood loss, and minimize soft-tissue damage with resultant reduced postoperative pain and disability.

METHODS

The authors queried the national, multicenter Quality Outcomes Database (QOD) registry for patients undergoing posterior lumbar fusion between July 2014 and December 2015 for Grade I degenerative spondylolisthesis. The authors recorded baseline and 12-month patient-reported outcomes (PROs), including Oswestry Disability Index (ODI), EQ-5D, numeric rating scale (NRS)–back pain (NRS-BP), NRS–leg pain (NRS-LP), and satisfaction (North American Spine Society satisfaction questionnaire). Multivariable regression models were fitted for hospital length of stay (LOS), 12-month PROs, and 90-day return to work, after adjusting for an array of preoperative and surgical variables.

RESULTS

A total of 345 patients (open surgery, n = 254; MIS, n = 91) from 11 participating sites were identified in the QOD. The follow-up rate at 12 months was 84% (83.5% [open surgery]; 85% [MIS]). Overall, baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts. Two hundred fifty seven patients underwent 1-level fusion (open surgery, n = 181; MIS, n = 76), and 88 patients underwent 2-level fusion (open surgery, n = 73; MIS, n = 15). Patients in both groups reported significant improvement in all primary outcomes (all p < 0.001). MIS was associated with a significantly lower mean intraoperative estimated blood loss and slightly longer operative times in both 1- and 2-level fusion subgroups. Although the LOS was shorter for MIS 1-level cases, this was not significantly different. No difference was detected with regard to the 12-month PROs between the 1-level MIS versus the 1-level open surgical groups. However, change in functional outcome scores for patients undergoing 2-level fusion was notably larger in the MIS cohort for ODI (−27 vs −16, p = 0.1), EQ-5D (0.27 vs 0.15, p = 0.08), and NRS-BP (−3.5 vs −2.7, p = 0.41); statistical significance was shown only for changes in NRS-LP scores (−4.9 vs −2.8, p = 0.02). On risk-adjusted analysis for 1-level fusion, open versus minimally invasive approach was not significant for 12-month PROs, LOS, and 90-day return to work.

CONCLUSIONS

Significant improvement was found in terms of all functional outcomes in patients undergoing open or MIS fusion for lumbar spondylolisthesis. No difference was detected between the 2 techniques for 1-level fusion in terms of patient-reported outcomes, LOS, and 90-day return to work. However, patients undergoing 2-level MIS fusion reported significantly better improvement in NRS-LP at 12 months than patients undergoing 2-level open surgery. Longer follow-up is needed to provide further insight into the comparative effectiveness of the 2 procedures.